Navigation Links
First Patients Enrolled in Phase II Trial With Intravenous Iclaprim in HAP/VAP/HCAP
Date:12/12/2007

days after the end of therapy. The primary endpoint will be the clinical cure rate at the TOC visit.

Progress of Phase I programme with oral iclaprim

The completed Phase I study was designed as a double-blind, placebo-controlled, dose escalation trial. A total of 32 subjects participated in the study (16 males and 16 females). Safety and tolerability were evaluated after administration of supra-therapeutic doses aimed at determining the maximal tolerated dose.

No serious adverse events were reported. Only after administering five-fold the targeted therapeutic dose, the number of adverse events showed a significant increase relative to placebo and this dose was then defined as the maximal tolerated dose in humans. All reported adverse events were mild-to-moderate in nature and mainly concerned vomiting and nausea. As in previous clinical trials with iclaprim, ECG monitoring was conducted. No clinically relevant increases in the QTc interval were observed at any of the investigated doses.

A further Phase I study, investigating the safety and tolerability of multiple administration of supra-therapeutic doses of oral iclaprim is currently ongoing. In addition, slow-release administration at supra-therapeutic doses is being investigated.

"Rolling" NDA for intravenous iclaprim in cSSSI; electronic submission of first modules due before year-end 2007

Arpida has made very good progress in compiling the New Drug Application (NDA) for intravenous iclaprim in its first indication, complicated Skin and Skin Structure Infections (cSSSI). The NDA forms the basis for the U.S. Food and Drug Administration (FDA) for its evaluation of a drug candidate's eligibility for marketing approval.

Arpida has agreed with the U.S. FDA to file the NDA in a rolling process. Using a 'rolling NDA' allows the different modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Test
'/>"/>

SOURCE Arpida Ltd
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. GlaxoSmithKline Recognizes University of Michigans Dr. Daniel F. Hayes as the First Recipient of the Gianni Bonadonna Breast Cancer Award
3. Kewaunee Scientific Announces First Quarter Results and Quarterly Dividend
4. Genmab Announces 2007 First Half Year Results
5. Pharsight Achieves First License Sale for Public-Source Database
6. Novare Announces First Ever Single Port Laparoscopic Kidney Removal (Nephrectomy) Using RealHand(TM) HD Instruments
7. ExonHit Therapeutics: Allergan and ExonHits First Collaboration Compound to Begin Human Clinical Trials
8. China Medical Technologies Reports First Quarter Financial Results
9. Pressure BioSciences, Inc. Issued First Patent in Canada
10. Peregrine Pharmaceuticals to Announce First Quarter FY 2008 Financial Results
11. Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... PA (PRWEB) January 14, 2014 Date: Friday, ... , Location: Warrington Country Club, 1360 Almshouse Road, Warrington, Pa. ... national nonprofit organization solely dedicated to finding a cure for ... affected worldwide, will host its annual Crystal Ball on Friday, ...
(Date:1/14/2014)... , Jan. 14, 2014  3D Communications, a leading provider of strategic ... business, and media events in the United States ... associate Virginia Cox , JD, is returning to the firm,s ... Cox re-joins 3D after more than two years of service ...
(Date:1/14/2014)... 2014 The largest international professional organization of ... therapeutic derivatives thereof has endorsed an educational program ... the challenges of adulterated herb and botanical products. ... The Society for Medicinal Plant and Natural ...
(Date:1/14/2014)... In recent years, growing suspicion about the pharmaceutical ... and promotion has led to unprecedented levels of public ... about the insidious impact of commercialization of research, has ... the world’s biggest pharmas for illegal marketing activities, allegations ...
Breaking Biology Technology:Hepatitis B Foundation to Host Annual Crystal Ball Gala 2Former FDA Associate Commissioner Returns To 3D Communications 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 2The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 3
... fruit fly and roundworm,s functional genomic elements: DNA sequences in ... are turned on and off at various times in different ... Human Genome Project, the genomes of the fruit fly, ... are powerful models for understanding human biology and disease, ...
... 22, 2010 Pathfinder LLC, a private biotechnology company ... cell damage ("Pathfinder"), and SyntheMed, Inc. (OTC Bulletin Board: ... the "Company"), today announced that they have entered into ... renamed  "Pathfinder Cell Therapy, Inc." and the combined company ...
... Inc. (Nasdaq: NVAX ) and scientists at ... Trudy Morrison, published in the January 2011 issue of ... novel virus-like particle (VLP) vaccine candidate against respiratory syncytial ...  This vaccine candidate has been created with technology that ...
Cached Biology Technology:Scientists reveal how biological activity is regulated in fruit fly and roundworm genomes 2Scientists reveal how biological activity is regulated in fruit fly and roundworm genomes 3Scientists reveal how biological activity is regulated in fruit fly and roundworm genomes 4Pathfinder LLC and SyntheMed, Inc. Announce Merger Agreement 2Pathfinder LLC and SyntheMed, Inc. Announce Merger Agreement 3Pathfinder LLC and SyntheMed, Inc. Announce Merger Agreement 4Pathfinder LLC and SyntheMed, Inc. Announce Merger Agreement 5Pathfinder LLC and SyntheMed, Inc. Announce Merger Agreement 6NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate 2NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate 3NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate 4
(Date:4/17/2014)... way the immune system may fight cancers and viral ... cells to treat illness. , The research, in mice, ... "neighborhood police" specialized squads of defenders that patrol ... entire city, the body. , Scientists at Washington University ... the liver, skin and uterus each has dedicated immune ...
(Date:4/17/2014)... of our ideas about domestication derive from Charles ... by British animal-breeding practices during the 19th century, ... improvement. , It is from Darwin that ... of captive animals from wild species and total ... But animal management in this industrial setting has ...
(Date:4/16/2014)... Florida State University researchers have identified a new ... bone density and muscle mass with obesity. , "It ... were the better your bones would be because the ... Hazel Stiebeling Professor of Nutrition at Florida State. "But, ...
Breaking Biology News(10 mins):Some immune cells defend only 1 organ 2The story of animal domestication retold 2The story of animal domestication retold 3The story of animal domestication retold 4Researchers: Obesity can amplify bone and muscle loss 2
... A new study from Boston University School of Medicine ... (iPS) cells in an experimental model were not rejected ... published online in Cell Stem Cell , demonstrates ... types that could offer treatment for a wide range ...
... Research Institute (TSRI) have been awarded approximately $1.2 million ... the National Institutes of Health to identify, test and ... of diseases, including rheumatoid arthritis, heart disease and several ... director in TSRI,s Translational Research Institute, and Peter S. ...
... German . , The detector combines near-unity ... very low error rate. The results have been published ... and reliable single-photon detectors are among the most sought-after ... yet reached maturity for practical application. Physicist Dr. Wolfram ...
Cached Biology News:BUSM study shows potential of differentiated iPS cells in cell therapy without immune rejection 2Grant to fund development of drug candidates for rheumatoid arthritis, neurodegenerative disorders 2Quantum communication: Each photon counts 2